Summary
At this course, you get a thorough understanding of ICH-GCP as well as the statutory and practical aspects of executing and monitoring clinical drug trials in Denmark. The course consists of presentations from authorities and experts in clinical trials complemented by group work and cases.
The starting point of this course is current legislation and guidelines and the different roles and responsibilities of monitors and investigators/study nurses.
Furthermore, focus is on site management from the site and sponsor’s/CRO’s point of view, giving you a unique opportunity to optimise your collaboration with your partners.
To achieve a Diploma you must pass the exam, which is held approximately four weeks after the course. The exam must be purchased separately . If you do not take the exam, you will receive a certificate of completion.
This is what course participants say
"It was a very well-planned course with good lectures and course leaders who had a great overview and managed the course very well."
Pernille Videbæk Pedersen, GCP-Coordinator, Aarhus University.
"It was a very well-structured course, which academically had a high level."
Pernille Skovby, National Coordinator at DanPedMed.
Keywords
- Good Clinical Practice ICH-GCP
- National legislation
- Audit and inspection
- Essential documents
- Safety reporting
- Site management from site and sponsor’s/CRO’s perspective
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Course leader & lecturers
- Birgitte HorstCourse leaderAuditor, GCP-koordinator
GCP-Enheden - Lene PalfeltCourse leaderCompetency Development Specialist
Novo Nordisk A/S - Eva Gjerlevsen HarreskovLecturerProject Data Manager
Novo Nordisk A/S - Lene EskildsenLecturerHead of Quality Assurance
Vicore Pharma AB - Lene Grejs PetersenLecturerChefkonsulent
Lægemiddelstyrelsen - Heidi Filtenborg MadsenLecturerSenior Specialist, QPPV Office
Lundbeck A/S - Charlotte CalovLecturerHead of the GCP Unit at Odense University Hospital
GCP-enheden ved Odense Universitetshospital - Amalie Engemand HenriksenLecturerAssociate Director, Global Clinical Drug Supply
Genmab A/S - Solveig Nordahl JacobsenLecturerAkademisk medarbejder, cand.pharm.
National Videnskabsetisk Komité - Pernille Ask AaboLecturerGCP Koordinator; M.Sc.Pharm
GCP-enheden - Trine Welløv BoesgaardLecturerMedical Director
Y-mAbs Therapeutics A/S - Christine Boiden SøtofteLecturerDPO-konsulent, cand.jur.
Center for Politik og Kommunikation, Region Hovedstaden
Is this course for you?
This diploma course is a basic training aimed at new monitors, project nurses, and investigators. It is an advantage to have some experience in the field.
What you will learn
- How to comply with the ICH-GCP and other clinical trial related regulations and guidelines, when conducting and monitoring clinical trials.
- What the roles of the involved authorities are – and how to interact both as investigator and as sponsor
- How roles and responsibilities are defined for sponsor/CRO and site - and how you can optimize the collaboration between the involved partners
- How to collect, monitor and file clinical trial related data throughout the clinical trial
- The importance of timely and accurate management of safety data
- The importance of correct handling of study medication from packaging to destruction
What your company will get
- A GCP professional who knows the essence of current ICH-GCP and how to ensure compliance
- A GCP professional who can provide valuable input to other team members regarding ICH-GCP guidelines and relevant regulations
- A GCP professional who knows the principles and practical aspects of effective site monitoring
- An employee who knows how the importance of good collaboration with relevant stakeholders in clinical trials
- An employee who understands the responsibilities and duties of both investigator and sponsor
Course calendar
Day 1
- Basic study design
- ICH-GCP
- The role and responsibility of investigators
- Investigator’s oversight (R2)
- The role and responsibility of sponsors
- Group work
- Involved authorities
- The Danish Medicines Agency
- The Privacy Act
- The National Committee on Health Research Ethics
Day 2
- Essential documents
- Protocol
- ICF
- Delegation log
- Site file - Contract + SOP contracts
- Areas of responsibilities for site and monitor
- Clinical trial data handling (collection)
- Standards for trial data
- Standards for record keeping
- CRF
- Source data list
- Workshop
- Safety reporting
- Definitions - Standards for reporting
- Areas of responsibilities for site and monitor
- Handling of medicine in clinical trials
- Distribution of roles – site vs. monitor
- Accountability
- Recipient control on site
- Labeling incl. add-on labeling
- Destruction
- Annex 13
Day 3
- Clinical trial data handling (monitoring)
- Access to electronic patient journals
- Risk based monitoring - SDV/SDR - Data management
- Practical monitoring and collaboration between monitor and site
Registration
Registration deadline13 Sep 2023
Lersø Parkallé 101
2100 København Ø
Day 1
- Basic study design
- ICH-GCP
- The role and responsibility of investigators
- Investigator’s oversight (R2)
- The role and responsibility of sponsors
- Group work
- Involved authorities
- The Danish Medicines Agency
- The Privacy Act
- The National Committee on Health Research Ethics
Day 2
- Essential documents
- Protocol
- ICF
- Delegation log
- Site file - Contract + SOP contracts
- Areas of responsibilities for site and monitor
- Clinical trial data handling (collection)
- Standards for trial data
- Standards for record keeping
- CRF
- Source data list
- Workshop
- Safety reporting
- Definitions - Standards for reporting
- Areas of responsibilities for site and monitor
- Handling of medicine in clinical trials
- Distribution of roles – site vs. monitor
- Accountability
- Recipient control on site
- Labeling incl. add-on labeling
- Destruction
- Annex 13
Day 3
- Clinical trial data handling (monitoring)
- Access to electronic patient journals
- Risk based monitoring - SDV/SDR - Data management
- Practical monitoring and collaboration between monitor and site
Registration
Registration deadline6 Mar 2024
Lersø Parkallé 101
2100 København Ø
Day 1
- Basic study design
- ICH-GCP
- The role and responsibility of investigators
- Investigator’s oversight (R2)
- The role and responsibility of sponsors
- Group work
- Involved authorities
- The Danish Medicines Agency
- The Privacy Act
- The National Committee on Health Research Ethics
Day 2
- Essential documents
- Protocol
- ICF
- Delegation log
- Site file - Contract + SOP contracts
- Areas of responsibilities for site and monitor
- Clinical trial data handling (collection)
- Standards for trial data
- Standards for record keeping
- CRF
- Source data list
- Workshop
- Safety reporting
- Definitions - Standards for reporting
- Areas of responsibilities for site and monitor
- Handling of medicine in clinical trials
- Distribution of roles – site vs. monitor
- Accountability
- Recipient control on site
- Labeling incl. add-on labeling
- Destruction
- Annex 13
Day 3
- Clinical trial data handling (monitoring)
- Access to electronic patient journals
- Risk based monitoring - SDV/SDR - Data management
- Practical monitoring and collaboration between monitor and site
Registration
Registration deadline4 Sep 2024
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.
Please familiarize yourself with the mandatory readings before starting the course.
The mandatory readings are also part of the examination syllabus.
Prerequisites
Experience with contractual relations in clinical trials is an advantage, but not a requirement.
Examination
The exam is held online, usually 4-6 weeks after the course.
You will receive a link with exam questions via your personal Atrium log-in.
In order to participate in the exam, you must have attended the course.
Course leaders
GCP-Enheden
Novo Nordisk A/S
Lecturers
Novo Nordisk A/S
GCP-Enheden
Vicore Pharma AB
Lægemiddelstyrelsen
Lundbeck A/S
Novo Nordisk A/S
GCP-enheden ved Odense Universitetshospital
Genmab A/S
National Videnskabsetisk Komité
GCP-enheden
Y-mAbs Therapeutics A/S
Center for Politik og Kommunikation, Region Hovedstaden
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